JXO — Enzyme Immunoassay, Cocaine Class II
FDA product code JXO covers "Enzyme Immunoassay, Cocaine", a Class II medical device regulated under 21 CFR 862.3250. Submissions are reviewed by the Clinical Toxicology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JXO
- Device Class
- Class II
- Regulation Number
- 862.3250
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201228 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | Jun 25, 2021 |
| K111925 | Psychemedics | PSYCHEMEDICS COCAINE EIA | May 1, 2012 |
| K923314 | Serex | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | Aug 24, 1992 |
| K921140 | Solarcare Technologies Corp | STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA | Aug 20, 1992 |
| K915785 | Solarcare Technologies Corp | STC DIAGNOSTICS BENZOYLECGONINE EIA | Mar 11, 1992 |
| K913737 | Instrumentation Laboratory | IL TEST(TM) COCAINE | Dec 3, 1991 |